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Head of MSAT Technology Transfer

roche · Shanghai

Senior 🇬🇧 English
cGMP Technology Transfer Process Validation IOPQ APS Scale-up

Job description

About the role

Roche is looking for a leader to head its MSAT Technology Transfer function at a new greenfield biopharmaceutical manufacturing facility in Shanghai. The role covers end-to-end technology transfer and operational readiness in a cGMP environment, including complex technical transfers, process development, site design, qualification, start-up and ramp-up. It is a technical and leadership position that works closely with MFG, QA and ENG and with global teams.

Key responsibilities

  • Lead technology transfer, PPQ introduction and compliance to secure manufacturing readiness, including qualification, start-up and ramp-up
  • Oversee operations tied to tech transfer: process design, troubleshooting, cGMP adherence and compliance with Roche quality policies and international regulations
  • Drive technical innovation by evaluating and implementing advanced technologies that improve process control, automation and product quality
  • Lead and develop a high-performing team, applying VACC leadership behaviours, and build a talent pipeline and succession plans
  • Advocate for diversity, equity and inclusion, and oversee site SHE procedures and safety culture
  • Contribute to the design and construction of the new facility, including IOPQ, APS and process validation
  • Act as a technical SME in upstream and downstream process transfer, scale-up and validation, and troubleshoot during start-up and early production
  • Collaborate with global teams on process intensification, bioreactor design, downstream processing and digitalization, and represent the site in regulatory inspections and audits
  • Lead cross-functional projects between R&D, engineering, quality and site operations

Required profile

  • Bachelor's degree (Pharmaceutical or Biological preferred)
  • Over 10 years of MSAT experience in the injection pharmaceutical industry; MNC biopharma preferred
  • At least 5 years of hands-on technology transfer experience
  • Minimum 5 years in people management with a track record of leading and developing teams
  • Experience in strategic projects for aseptic filling facilities, including design, commissioning and qualification
  • Strong knowledge of cGMP and pharmaceutical regulations, especially for biologics
  • Fluent English and strong communication skills

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Source : ats:workday

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Published 1 week ago

Expires 1 month from now

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roche

Shanghai